Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of atrisk skin, to improved patient outcomes and reduced care costs. Convatec’s revenues in
2023 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit http://www.convatecgroup.com.

Our search for better is changing the lives of our customers. It’s changing the careers of our people too –creating new challenges and opportunities all the time. We’re a business that never stands still. Join us on our journey to #ForeverCaring as Senior Quality Systems Specialist, and you won’t either.

 

This is a key role within the Global Quality function, where you will support global oversight of the Recall/Market Action Processes, ensure compliance to FDA 21 CFR Part 820, FDA 21 CFR Part 806, ISO 13485:2016, Medical Device Single Audit Program and other applicable global Quality System Regulations.

The Senior Quality Systems Specialist will also assist in maintaining the global Field Safety Notice, Recall and any other Market Actions Processes including monitoring process performance and implementing continuous process improvements.

About the Role:

Key Duties & Responsibilities

• Support other Quality System Activities as required (Audits, Management Review, Non-Conformance, Corrective Action/Preventive Action).
• Provide global oversight and guidance of Field Safety Notice and Market Actions Processes and Framework.
• Work both cross functionally and across sites with a sense of urgency to ensures timely, compliant, and effective Field Safety Notice, Recall or any other Market Actions.
• Develop procedures and work instructions required for the execution of Field Safety Notice, Recall or any other Market Action.
• Deliver cross-functional training associated with the decision and progress Field Safety Notice, Recall or any other Market Action.
• Support internal and external audit activities including FDA Inspections and ISO certification/surveillance audits.
• Proactively identify areas of opportunity within the Market Action Process and provides solutions for improvement.

About You:

The ideal candidate should bring the following qualities to the role:

• Intermediate to expert skill level working on Market Actions (Recall, Field Safety Notice).
• Knowledge of and the ability to translate and apply the requirements of ISO 13485:2016, 21 CFR Part 820, FDA 21 CFR Part 806, and the Medical Device Single Audit Program (MDSAP).
• Ability to deal with difficult situations with tact and professionalism.
• Ability to communicate effectively in both oral and written communications, and work with employees at all levels of the organization.
• Intermediate to Expert skill level utilizing TrackWise (or other EMS/platform).
• Strong problem solving and trouble shooting skills.
• Proficient computer skills: MS Office (Outlook, PowerPoint, Word, Power-Bi, and Excel), Teams, and Adobe Acrobat Pro.
• Ability to communicate with diverse teams and functions to foster efficient processes, continuous improvement, and integration across the organization. 
• High level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal direction.
• Excellent stakeholder management experience and the ability to liaise with customers, end users and regulatory authorities.

Travel Requirements

This position may involve travel up to 10% of the time, this may include overseas travel. Most trips will include overnight travel.

Education/Qualifications

Bachelor’s Degree in Science, Engineering, Regulatory Affairs, Medicine, or related discipline preferred

Demonstrated record of working successfully within a matrix environment.

Minimum 5 years supporting a global Quality Management System process in the medical device or pharmaceutical industry.

Working Conditions:

This is a remote position but office presence will be required or allowed for certain meetings, events, or to meet certain business needs.

Language Skills Required:

Speaking:                 Yes   English

Writing/Reading:    Yes    English

 

Our ambitions will bring the very best out in you. You’ll be pushed to aim higher and really own your work. You’ll be encouraged and supported to make things happen too.  It can be challenging.   But, as the progress you make will help improve the lives of millions, it’ll be worth it.

This is stepping up to a challenge.

This is work that’ll move you.

#ForeverCaring #ForeverConvatec #WeAreConvatec

#LI-DB1

#LI-Remote

 

Beware of scams online or from individuals claiming to represent Convatec

A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.

If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at [email protected].

Equal opportunities

Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives

Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Already a Convatec employee?

If you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and View "Convatec Internal Career Site - Find Jobs". Thank you!